Judge Hammers Abbott’s Patent

Posted on | September 21, 2008 | No Comments

2008-1511-1514 Therasense v. Becton, Dickson
ND/CA 04-02123 and other consolidated actions
Judge William Alsup

Plaintiffs Therasense and Abbott appeal from the judgment of Judge William Alsup finding in favor of defendants that (i) claims 1-4 of 5,820,551 (co-owned by Abbott and Therasense) are invalid as obvious and (ii) the ’551 is unenforceable by reason of inequitable conduct.

The ’551 is generally directed to an electrochemical sensor for measuring the amount of glucose in a sample of blood.  It was in prosecution for over 14 years and, on 12 occassions, had claims rejected based on U.S. Patent 4,545,382 and its European counterpart (the ’636)–patents which included some of the same inventors from the ’551.

To overcome the repeated rejections from the PTO based on the ’382 and ’636 patents, one of Abbott’s patent counsel:

struck upon a new point of possible novelty previously overlooked in the pending prosecution. The new point was that the specification disclosed a sensor for use in whole blood without any protective membrane. Trouble was, a passage in the earlier ’382 patent already seemed to disclose membraneless sensors. That passage read (col. 4:63–66):

Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules.

To address this problem, Abbott decided to assert, as a matter of extrinsic fact, that in 1983 skilled artisans would have believed that a membrane was essential even in the face of the ’382 disclosure, i.e., they would not have taken the quoted sentence literally.

Abbott proceeded to submit inventor declarations and other material to the PTO, and eventually secured an allowance.

The court reviewed the prosecution history of all of the patents, and concluded that the representations made by Abbott regarding the ’551 were intentionally inconsistent with those made to the EPO regarding the ’636:

The court found the statements were plainly material to the prosecution, and also found an intent to deceive.  Abbott’s prosecuting attorney was permitted to appear at trial and testified, but the court found that he "did not prove to be a convincing witness," describing his explanations as "not plausible" and "not credible."

When, for example, Attorney Pope was shown the EPO appeal language quoting the sentence in question and immediately stating that “[i]t is submitted that this disclosure is unequivocally clear,” he testified that he had understood the “unequivocally clear” characterization to refer only to the last six words of the 26-word sentence — that is, to the concluding phrase “permeable to water and glucose molecules” and not to its other twenty words. Sadly, this order must find that Attorney Pope had no plausible reason for consciously withholding the EPO submissions and that he acted with specific intent to deceive Examiner Shay and the PTO. In making this finding, this Court has taken into account the demeanor of Attorney Pope during his trial testimony.

Attorney Pope testified that his motive was to obtain a strong patent. Therefore, he said he had no motive to conceal and to thus undermine the enforceability of the patent. This argument conveniently overlooks the fact that he consciously chose to withhold. Counsel who steer a course toward obtaining a strong patent should err on the side of disclosure, not nondisclosure. And, it must be said, after so many rejections over so many years, it seems clear that Abbott’s primary goal was to eke out some claim, saving a fight over enforceability for a later day.

Attorney Pope also said that patent prosecutors often write specifications broadly so as to support broad claims, cutting back on their claims as they go along as necessary to avoid the prior art or as is otherwise necessary. Being aware of this alleged practice, he testified that he, therefore, read “optionally, but preferably” as an overblown way for a prior patent prosecutor to have said “optionally, but always.” This is unconvincing. First, there is no authority for this secret-code theory. Words are supposed to mean what they say. Otherwise, our patent-disclosure system would collapse. Second, since the claims of the ’382 covered membraneless sensors used in blood, as both sides agree, the specification must have been sufficient to support the membraneless sensors.

As a result, the court concluded that the ’382 invalidated claims 1-4, and that the omissions and misrepresentations during prosecution of the ’551 rendered the patent unenforceable.

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Findings and Conclusions

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